Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
132.24 mg/m³
Explanation for the modification of the dose descriptor starting point:

For workers: corrected inhalatory N(L)OAEC =oral N(L)OAEL x (1/sRVrat) x (ABS oral -rat/ABS inh -human) x (sRVhuman /wRV)

= N(L)OAEC = 150 mg/kg bw/day x (1/0.38 m3/kg/d) x (50%/100%) x(6.7 m3 / 10 m3) = 132 mg.m3

AF for dose response relationship:
1
Justification:
A clear NOAEL was used to derive the DNEL
AF for differences in duration of exposure:
6
Justification:
Default factor for extrapolating between subacute and chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
None required. Taken into account during correction of starting point
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
Sufficient data for the tonnage
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.12 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
264 mg/m³
Explanation for the modification of the dose descriptor starting point:

For workers: corrected inhalatory N(L)OAEC =oral N(L)OAEL x (1/sRVrat 4 hours) x (ABS oral -rat/ABS inh -human) x (sRVhuman /wRV)

= N(L)OAEC = 150 mg/kg bw/day x (1/0.19 m3/kg/d) x (50%/100%) x(6.7 m3 / 10 m3) = 264 mg.m3

AF for dose response relationship:
1
Justification:
A clear NOAEL was used to derive the DNEL
AF for interspecies differences (allometric scaling):
1
Justification:
None required. Taken into account during correction of starting point
AF for other interspecies differences:
2.5
Justification:
Default for remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
database adequate for the tonnage
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
Value:
150 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

dermal NOAEL = Oral NOAEL x (oral absorption/dermal absorption) =

150 mg/kg bw/day x (100% / 100%) =150 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEL was used to derive the DNEL
AF for differences in duration of exposure:
6
Justification:
Default factor for extrapolating between subacute and chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for extrapolating between rat and man
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
Sufficient data for the tonnage
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

dermal NOAEL = Oral NOAEL x (oral absorption/dermal absorption) =

150 mg/kg bw/day x (100% / 100%) =150 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEL was used to derive the DNEL
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for extrapolating between rat and man
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
Sufficient data for the tonnage
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

As a result of the exposure scenarios derived for the chemical safety assessment, no exposure to the general population is expected.